FDA Outlines Cefaly Device Special Controls

About four months ago, the agency allowed it to be marketed as a preventative treatment for migraines.

The U.S. Food and Drug Administration has published a final rule listing the special controls that address the identified risks in using the Cefaly Device or similar devices. Approved in March 2014 by FDA to be marketed, the Cefaly Device is a patented, drug-free, battery-powered, prescription device that treats migraine pain with neurostimulation.

The FDA final order published July 3 says the special controls, in addition to general controls, "will provide reasonable assurance of the safety and effectiveness of this device." The special controls cover analysis and testing, labeling and warnings, software testing, and more. Any firm submitting a premarket notification for a transcutaneous electrical nerve stimulator to treat headaches will need to comply with them.

The Cefaly Device has been classified into class II, and FDA can exempt devices in that category from premarket notification requirements. But its order says for this type of device, FDA has determined premarket notification is necessary.

Download Center

HTML - No Current Item Deck
  • Safety Management Software - Free Demo

    IndustrySafe Safety Software’s comprehensive suite of modules help organizations to record and manage incidents, inspections, hazards, behavior based safety observations, and much more. Improve safety with an easy to use tool for tracking, notifying and reporting on key safety data.

  • Create Flexible Safety Dashboards

    IndustrySafe’s Dashboard Module allows organizations allows you to easily create and view safety KPIs to help you make informed business decisions. Our best of breed default indicators can also save you valuable time and effort in monitoring safety metrics.

  • Schedule and Record Observations

    IndustrySafe's Observations module allows managers, supervisors, and employees to conduct observations on employees involved in safety critical behavior. IndustrySafe’s pre-built BBS checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Why Is Near Miss Reporting Important?

    A near miss is an accident that's waiting to happen. Learn how to investigate these close calls and prevent more serious incidents from occurring in the future.

  • Get the Ultimate Guide to Safety Training

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common FAQs.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - April 2019

    April 2019

    Featuring:

    • ELECTRICAL SAFETY
      Taking the Guesswork Out of De-Energizing Industrial Equipment 
    • VISION PROTECTION
      Four Simple and Effective Ways to Avoid Digital Eye Strain
    • FOOT PROTECTION
      PPE the Automotive Industry Needs to Invest In
    • FIRE SAFETY
      Eliminate 10 Fire Hazards That May Be in Plain Sight
    View This Issue